NCT07739784

Brief Summary

The goal of this observational study is to learn whether personality traits are related to eye side effects from glaucoma medications in adults who currently use or previously used these medications. The main questions this study aims to answer are: Are certain personality traits associated with the occurrence or severity of eye side effects from glaucoma medications? Do personality traits differ between people who experience these side effects and those who do not? Participants will complete a questionnaire that measures five personality traits: openness, conscientiousness, extraversion, agreeableness, and neuroticism. They will also provide basic demographic information. The researchers will review participants' medical records to collect information about their glaucoma medications and any related eye side effects, including the type and frequency of side effects and whether treatment was changed because of them. Participation involves one session lasting approximately 30 minutes. Questionnaires may be completed securely online or in person at the clinic. The study will include approximately 352 adults. No treatment will be assigned or changed as part of this study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Feb 2026Aug 2027

Study Start

First participant enrolled

February 25, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 28, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

adverse eventsPersonality traitsglaucoma

Outcome Measures

Primary Outcomes (1)

  • Difference in Five-Factor Model neuroticism scores between participants with and without significant ocular adverse reactions

    Neuroticism will be measured using the neuroticism domain of the Five-Factor Model personality questionnaire. Mean neuroticism scores will be compared between: Cases: participants who experienced at least one ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. Controls: participants who did not experience a significant ocular adverse effect resulting in medication discontinuation. Higher neuroticism scores indicate a higher level of the neuroticism personality trait.

    Assessed once during the single study session, lasting approximately 30 minutes.

Study Arms (2)

Case

Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication.

Other: No Interventions

Control

Participants without a documented significant ocular adverse effect resulting in medication discontinuation.

Other: No Interventions

Interventions

There is no intervention

CaseControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 352 adults with glaucoma who are currently receiving or have previously received treatment with one or more glaucoma medications will be recruited from the McGill Academic Eye Centre and the Lachine Hospital Ophthalmology Clinic. Participants will be classified into two groups: Cases: Participants with at least one documented ocular adverse effect from a glaucoma medication that resulted in discontinuation of the medication. Controls: Participants without a documented significant ocular adverse effect resulting in medication discontinuation. Approximately 176 participants will be included in each group

You may qualify if:

  • Age 18 years or older.
  • Diagnosis of glaucoma.
  • Current or previous treatment with one or more glaucoma medications.
  • Able to provide informed consent.
  • Able to complete the study questionnaires in English or French.

You may not qualify if:

  • Uncontrolled anxiety or depression that was present before glaucoma medication treatment began.
  • Unable to provide informed consent.
  • Unable to complete the study questionnaires in English or French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center

Montreal, Quebec, Canada

RECRUITING

Related Publications (5)

  • Inoue K. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014 May 12;8:903-13. doi: 10.2147/OPTH.S44708. eCollection 2014.

  • Gazzard G, Konstantakopoulou E, Garway-Heath D, Adeleke M, Vickerstaff V, Ambler G, Hunter R, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension. Ophthalmology. 2023 Feb;130(2):139-151. doi: 10.1016/j.ophtha.2022.09.009. Epub 2022 Sep 17.

  • Davis C, Ralevski E, Kennedy SH, Neitzert C. The role of personality factors in the reporting of side effect complaints to moclobemide and placebo: a study of healthy male and female volunteers. J Clin Psychopharmacol. 1995 Oct;15(5):347-52. doi: 10.1097/00004714-199510000-00007.

  • Dahl AA, Smedsland SK, Vandraas KF, Bohn SK, Falk RS, Kiserud CE, Reinertsen KV. High neuroticism is associated with common late adverse effects in a nationwide sample of long-term breast cancer survivors. Breast Cancer Res Treat. 2023 Nov;202(1):97-104. doi: 10.1007/s10549-023-07055-2. Epub 2023 Aug 1.

  • Baudouin C. Detrimental effect of preservatives in eyedrops: implications for the treatment of glaucoma. Acta Ophthalmol. 2008 Nov;86(7):716-26. doi: 10.1111/j.1755-3768.2008.01250.x. Epub 2008 Jun 3.

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Hady Saheb, MD MPH

    MUHC RI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations